Official Newsjournal of the Illinois Council of Health-System Pharmacists

ICHP KeePosted

December 2017

Volume 43 Issue 10

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Feature

Let's Get Personal

Columns

President's Message

Directly Speaking

New Practitioners Network

Professional Affairs - Medication Safety Pearl

ICHPeople

Leadership Profile

Government Affairs Report

College Connection

High Risk Readmission Program: A Rotation Experience

More

Welcome New Members!

Officers and Board of Directors

ICHP Pharmacy Action Fund (PAC) Contributors

Upcoming Events

2015 Midyear

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Illinois Council of Health-System Pharmacists
4055 North Perryville Road
Loves Park, IL 61111-8653
Phone: (815) 227-9292
Fax: (815) 227-9294
www.ichpnet.org

KeePosted
Official Newsjournal of the Illinois Council of Health-System Pharmacists

EDITOR
Jacob Gettig

ASSISTANT EDITOR
Jennifer Phillips

MANAGING EDITOR
Scott Meyers

ASSISTANT MANAGING EDITOR
Trish Wegner

DESIGN EDITOR
Amanda Wolff

ICHP Staff
EXECUTIVE VICE PRESIDENT

Scott Meyers

VICE PRESIDENT - PROFESSIONAL SERVICES
Trish Wegner

DIRECTOR OF OPERATIONS
Maggie Allen

INFORMATION SPECIALIST
Heidi Sunday

CUSTOMER SERVICE AND
PHARMACY TECH TOPICS™ SPECIALIST

Jo Ann Haley

ACCOUNTANT
Jan Mark

COMMUNICATIONS MANAGER
Amanda Wolff

LEGISLATIVE CONSULTANT
Jim Owen

ICHP Mission Statement
Advancing Excellence in Pharmacy

ICHP Vision Statement
ICHP dedicates itself to achieving a vision of pharmacy practice where:
  • Pharmacists are universally recognized as health care professionals and essential providers of health care services.
  • Patients are aware of the training, skills, and abilities of a pharmacist and the fundamental role that pharmacists play in optimizing medication therapy.
  • Formally educated, appropriately trained, and PTCB certified pharmacy technicians manage the medication distribution process with appropriate pharmacist oversight.
  • Pharmacists improve patient care and medication safety through the development of effective public policies by interacting and collaborating with patients, other health care professionals and their respective professional societies, government agencies, employers and other concerned parties.
  • Evidence-based practices are used to achieve safe and effective medication therapies.
  • There are an adequate number of qualified pharmacy leaders within the pharmacy profession.
  • Pharmacists take primary responsibility for educating pharmacy technicians, pharmacy students, pharmacist peers, other health professionals, and patients about appropriate medication use.

KeePosted Vision
As an integral publication of the Illinois Council of Health-System Pharmacists, the KeePosted newsjournal will reflect its mission and goals. In conjunction with those goals, KeePosted will provide timely information that meets the changing professional and personal needs of Illinois pharmacists and technicians, and maintain high publication standards.

KeePosted is an official publication of, and is copyrighted by, the Illinois Council of Health-System Pharmacists (ICHP). KeePosted is published 10 times a year. ICHP members received KeePosted as a member benefit. All articles published herein represent the opinions of the authors and do not reflect the policy of the ICHP or the authors’ institutions unless specified. Advertising inquiries can be directed to ICHP office at the address listed above. Image disclaimer: The image used in the Pharmacy Tech Topics™ advertisement is the property of © 2015 Thinkstock, a division of Getty Images.

Copyright © 2015, Illinois Council of Health-System Pharmacists. All rights reserved.


Feature

Let's Get Personal


We want to stay in touch and help you get the most out of your ICHP membership! Share your personal email with us so we can be sure you receive important ICHP communications like CPE Programs, statewide meetings, Career Center, networking opportunities, and more! Sometimes institution firewalls block our emails from being delivered to your work email. Sharing your personal email with us is the best way to make sure you don’t miss out! We promise we won't share your email address with anyone else.

To share your personal email address with ICHP, please send an email to members@ichpnet.org. Don't forget to whitelist members@ichpnet.org, and ask your colleagues to do the same!

Thanks, and we look forward to keeping in touch!

Sincerely,
Scott, Trish, Maggie, Heidi, Jan, Jo, and Amanda
ICHP Staff

Columns

President's Message
Presidential Inaugural Address - Leadership: It’s Not Just for Leaders

by Jen Phillips, PharmD, BCPS, ICHP President

As I stand here looking out over the crowd, it warms my heart to see so many people who have played such a pivotal role in my career. As a student and a pharmacy technician, I was fortunate to have great role models who taught me many things not included in my pharmacy curriculum. Well, my luck has not yet run out because to this day, I am still surrounded by many inspirational co-workers, colleagues, and students who continue to teach, mold, and shape me into the person I will be tomorrow. From some, I have learned how to manage time when there are so many things to do. From some, I have learned diplomacy. Still others have taught me how to deal with conflict, how to motivate co-workers and students, and the value of taking time to personally get to know my colleagues. And, of course, in the mix of all of the people I’ve interacted with in the past 21 years of my pharmacy career, there have also been a few people who taught me how not to act, behave, or think. Regardless, everyone I have interacted with has had something to teach me. I would like to take the time to give all of my formal and informal mentors a great big thank you! I have tried my best to emulate all of your best characteristics, but I know that I still have a long way to go on my journey towards excellence.

As I look over the crowd, I also see many students, residents, and new practitioners. I want you to know that when I was where you are now, leadership development was one of the furthest things from my mind. I had no aspirations for holding any kind of leadership position. Why? Well, mostly because I felt unqualified to be a leader. Why? Well, you see, I had this idea in my head that leaders were “born”. I would look around at the great pharmacy leaders around me, the leaders of the pharmacy organizations, even the student leaders. They all seemed to be so dynamic and so motivating and so effective. What’s more, it all seemed to come so naturally to them. “Lucky for them”, I used to think. “They are born with that special skill.”

What I have come to learn over time, however, is that great leaders are not born, they are made. No one is born a great leader (just like no one is born knowing pharmacokinetics, or pharmacy law or how to counsel a patient on an inhaler). We learn these concepts in a classroom, but it is through practice, practice, and more practice, that we are able to continuously refine them. Leadership works the same way. Sure, there may be people who are naturally good at some aspects of leadership – like organizational skills, communication skills, team-building skills, etc. However, rarely do we find someone who is naturally good at everything. Leadership, just like any other set of skills, requires some basic education followed by opportunities to hone and practice those skills.

Well, that sounds like a lot of time and work, doesn’t it? And, admittedly, I am probably not doing a very good job of selling you this idea of leadership just yet. But, the idea needs to be sold. We are still in the midst of a leadership shortage. In 2004, an ASHP survey predicted a major leadership gap – a leadership “crisis” to be more exact. A survey performed at that time revealed that there were more leaders retiring and fewer and fewer people wanting to move into leadership roles. As a result of this survey, ASHP and other professional organizations began focusing on ways to increase leadership development among their members. A number of opportunities were created to help build the leaders of the future including:  workshops, certificates, courses, and degree programs, to name a few. Colleges were urged to focus more on “soft skill” and leadership development of students. ASHP has included leadership development for residents and residency preceptors into its accreditation standards. A repeat survey conducted in 2014 revealed that while these initiatives have resulted in some progress over the last 10 years, there is still work that needs to be done to prevent a leadership gap crisis within the next 10 years.

Well, here’s what I believe:
  1. I believe that our organization, ICHP, and our members can work together to help narrow this leadership gap.
  2. I believe that once you begin to learn and refine your leadership skills, you will find them to be immensely valuable in your everyday practice, regardless of whether you move into a leadership role or not.
This brings me to my theme for this presidential year, which is “Leadership: It’s not just for leaders”. The concept involves the tenet that leadership skills are necessary for all pharmacists, not just those in leadership positions. It is based on the Big L little L philosophy introduced by Sara White several years ago during her Harvey AK Whitney Award lecture. In this lecture, she detailed seven key elements to successful and effective leadership. Most of these elements are things that most pharmacists do every day. Most of us probably agree that if we sharpened our skills in these areas, we could be even more effective.

  • Leaders must work effectively to accomplish actual results. 
    • This involves having strong time management skills so that work can get done efficiently. It also involves continuously asking the question, “How can this process be done more efficiently or more effectively?” If you find yourself doing this already, then you are exhibiting leadership skills and I encourage you to continue doing this. If you have not, then I challenge you to step outside of your comfort zone and start doing this. You are the expert of your daily responsibilities and your insights and recommendations – especially if communicated in an effective manner – are extremely valuable and necessary to make effective change.
  • Leaders must persevere and persist.
    • Not all days are good days. I challenge you to take the time to remember why we chose this profession to begin with. This may help redefine your purpose and make the extra effort worth it. Changing your perspective to see challenges as opportunities can help you get through some of those difficult days.
  • Leaders must influence through attitude and approach.
    • This applies not only to the students, residents, and new practitioners that we train, but also to the colleagues that we work with on a day to day basis. People believe what they see much more than what they hear. I challenge you to try to be a positive role model for others and treat others with compassion and respect and remember that everyone has something to teach you.
  • Leaders must work well with others.
    • While this is not always easy, it is essential to a team-based environment. Developing skills in and improving our ability to manage emotions effectively can help us be successful in this arena.
  • Leaders must lead oneself so that people want to work with them.
    • I challenge you to lead by your example. As Gandhi once said, “Be the change you want to see in this world.”
  • Leaders must invest in their own future.
    • Ensuring professional competence is necessary for all of us. One way to do this is to have a continuing professional development portfolio. Other options include advanced certification, advanced degrees, workshops, and many others. What’s important is to identify the areas where you need additional development and work towards self-amelioration.
  • Leaders must have a written vision/mission statement.
    • While this is especially important for those in an official leadership capacity, it is also a great idea to have a personal vision/mission statement. The act of documenting your goals, ambitions, and plans is helpful in ensuring you stay on progress.
After hearing these seven attributes, I ask all of you – are you or can you be a leader? If you’ve answered “yes”, then you are well on the road to helping to shape our profession. If you’ve answered “no”, then I ask you to let ICHP know what we can do to get you there.

If you are looking for more opportunities to refine, build, or practice, your leadership skills, then ICHP has many opportunities available to you. ICHP provided the pathway I needed to help refine my leadership skills, and I want those same opportunities to be available to everyone else, including those interested in Big L positions and those who just want to be the best practitioner they can be. Leadership is not just for leaders and developing leadership skills is valuable for both types of individuals.

It is my hope that we can inspire more individuals within this organization to, at the very least, aim to increase their leadership skills to help them be more effective in their everyday practice. It is also my hope that we can inspire some to pursue Big L leadership positions – at their practice site or within ICHP.  I look around this room, and I see so much talent and I want to use it to help achieve our mission and goals and to help advance our profession.

To help roll out this theme, I am working with the Director of Educational Affairs to try to have leadership development programming at upcoming meetings that focuses on development of these types of skills. ICHP also has many opportunities available to you to start practicing your leadership skills, including serving on a committee or a division, leading a division or a subcommittee, serving as mentors for pharmacy students, or running for a position on the Board of Directors. I encourage you to step outside of your comfort zone. Others have so much to teach you, and you will be glad that you did.

I would like to end with a quote by Margaret Mead: “Never doubt that a small group of thoughtful committed citizens can change the world. Indeed, it is the only thing that ever has.”




Directly Speaking
How Do You Manage Your Own Life-Long Learning?

by Scott A. Meyers, Executive Vice President

At the end of October, I had the opportunity to participate in ACPE’s CPE Summit. The Summit was a brief look back at the first 40 years of continuing pharmacy education and then a deep dive into what could be in its future over the next 10-15 years. The Summit drew nearly 60 participants from across the nation, representing boards of pharmacy, CPE providers, national pharmacy leaders and ACPE Board and Commission members. The participants provided a wide range of insights and experiences. The deep dive into the future of CPE identified a concern. How do the attitudes of individual pharmacists impact their participation in CPE?

Every year for many years, graduating pharmacy students take the oath of a pharmacist at some point, usually during the graduation ceremony itself. In that oath is or should be one statement that drives every pharmacist’s attitude toward CPE.

"I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow:
  • I will consider the welfare of humanity and relief of suffering my primary concerns.
  • I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients.
  • I will respect and protect all personal and health information entrusted to me.
  • I will accept the lifelong obligation to improve my professional knowledge and competence.
  • I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct.
  • I will embrace and advocate changes that improve patient care.
  • I will utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists.
I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.”

But does this important highlighted bullet point drive pharmacists’ participation in CPE or is it merely the relicensure requirements by state licensing agencies? My guess is, it depends on the individual practitioner. Many of our colleagues “accept the obligation to improve (their) professional knowledge and competence” through not only participating in CPE activities but through the process of CPD (Continuing Professional Development). CPD is a process that directs life-long learning that many seasoned practitioners developed informally, long before it became formal and widely discussed. Perhaps our informal efforts weren’t quite as well organized or documented, but they certainly existed and have guided many pharmacists learning activities for many years.

CPD has been greatly discussed by ACPE providers, its Commission and its Board for several years (probably more than a decade). It has been recognized by many colleges of pharmacy which have taught students to build portfolios of their learning experiences. The North Carolina Board of Pharmacy has even offered CPD as an option for meeting its relicensure procedure. Even ICHP has included CPD tools in its statewide meeting syllabi for several years to help members embrace the formalized concept. And yet many pharmacists still don’t know what we’re talking about when we discuss CPD.

If you really think about CPD, provided you know the details of the process, it is actually a road map for common sense related to learning. To better illustrate this common sense approach, here is ACPE’s diagram of the process:

 
An important point to mention is that the CPD process above does not only relate to selecting learning activities that provide CPE credit but to a practitioner’s selection of all learning experiences whether it is reviewing the mechanisms of action, indications, dosage, cautions, and contraindications of a newly released medication, becoming familiar with a new procedure or a new technology, or examining the use of an existing medication in a newly published non-approved indication. CPD is the process of organized learning of any sort and is defined by ACPE as “a self-directed, ongoing, systematic and outcomes-focused approach to lifelong learning that is applied into practice.”¹

In the days before CPD formalization, practitioners took most of the steps of CPD but probably failed to record and review as much as they should have. The learning process was organized, identified the practitioner’s learning gaps, selected programs and activities that would fill those gaps and then applied that learning to practice. Simple, straight forward and dedicated to the idea that pharmacy practice can and should always be improved.

At the Summit, the participants believed that CPD should be a key tool in the future of CPE for ACPE. Why, you ask? Continuing Pharmacy Education is under scrutiny by many, the public, government agencies and the legislature because alone, it doesn’t seem to ensure competency. We’ve all seen colleagues sitting in CPE sessions reading newspapers, smart phones, tablets and laptops when they should have been paying attention to the presenters. We also know that people share program codes or post-test answers for live and home-study activities. In addition, lecture based learning activities have a limited way to measure learning and application of learning in the short time they occur.

Relicensure by examination is not a pleasant thought and developing a relicensure examination that would test practitioner competency for the varied ranges of generalists and specialists who now practice pharmacy would be expensive and nearly impossible. So CPD with effective documentation could be the next step to relieve public and governmental concerns.

The good news for many students and new grads is that you know how to do CPD thanks to your College of Pharmacy and the portfolios they made you create. The good news for seasoned practitioners is that you’ve learned a lot of new things since you graduated years ago, so this will just have to be another thing you get to learn and use.

Embracing CPD has become a higher priority for practitioners over the past decade, but we’re a long way from seeing it used profession-wide. From the discussions at the Summit, we could see a push by employers to use CPD to document competencies, one of many requirements of credentialing agencies. It is also possible that progressive Boards of Pharmacy offer CPD as an alternative to the simple CPE requirements. Regardless of these potential developments, as ACPE moves forward with what it learned at the recent CPE Summit, perhaps it will gain traction in more practitioners’ minds and attitudes. My question to you, “How do you manage your own lifelong learning?”

Reference:
¹ACPE. Continuing Professional Development Presentation. https://www.acpe-accredit.org/pdf/CPDConceptsACPEWebsiteFeb2015.pdf  (accessed 2015 November).




New Practitioners Network
Team ICHP Helped Stomp out T1DM at the Annual JDRF Walk

by Rebecca Castner, PharmD, Clinical Assistant Professor, Ambulatory Care, Chicago State University College of Pharmacy

The NPN continued its annual tradition of participation in the Juvenile Diabetes Research Foundation (JDRF) One Walk this year on Sunday, October 4th. The walk is held annually in multiple areas in Chicago; Team ICHP attended the scenic 5k circuit beginning at Montrose Harbor on Chicago’s north side.

You may wonder, why the NPN decided to participate in this walk in particular, when there are so many to choose from. When looking a little closer at what JDRF does, and what it has accomplished, it is easy to see why pharmacists appreciate and support this foundation. The Foundation is the largest non-governmental contributor to type 1 diabetes mellitus (T1DM) research, dedicated to moving new potentially lifesaving drugs through the research pipeline. The goal of JDRF is to not only improve the lives of those living with T1DM, but to one day find a cure for the disease and its complications through improved treatment options – aiming to “Turn Type One into Type None”. Some notable ventures supported by funding from JDRF include the development of LUCENTIS® (ranibizumab injection) which is used to treat and even reverse diabetic retinopathy in some patients, support of early research for “smart insulin,” and vaccine development to prevent T1DM. As pharmacists, those are definitely some things we can get behind!

This year, Team ICHP consisted of 9 walk fundraising participants and 5 generous donors. Together we were able to surpass our team goal of $500, raising a total of $570 for T1DM research! Unfortunately, some of the team members were unable to attend on walk day, but they were with those who attended in spirit! NPN members Janna Afanasjeva, Shubha Bhat, and Rebecca Castner represented the team at the event, and were supported by Janna’s husband. Attendees had a great time, and we hope to have an even larger team next year!


Left to right: NPN members Janna Afanasjeva, Rebecca Castner, and Shubha Bhat


Professional Affairs - Medication Safety Pearl
Update on the New FDA Pregnancy Categories

by Sibel Islamoglu, PharmD Candidate; Anne Misher, PharmD, PGY-2 Ambulatory Care Resident; Jennifer Phillips, PharmD, BCPS, Associate Professor, Pharmacy Practice, Midwestern University Chicago College of Pharmacy

Introduction
On June 30, 2015, changes to drug labeling of pregnancy and lactation sections were implemented to deliver more comprehensive and organized information for practitioners. A new format with more information replaced the pregnancy letter category system. This article provides an overview of the rationale and details of the changes in an effort to help prepare pharmacists to serve as valuable resource when interpreting and applying these recommendations.  

To appreciate why the change was enacted, it may be beneficial to review the current statistics of prescription medication in pregnant populations and the historical background of drug labeling legislation. One in every ten American women of childbearing age becomes pregnant annually, and approximately half of these are unintentional or unplanned. At least one prescription drug is used by 90% of pregnant women.1 On average, this population uses between three to five prescription drugs.2 Approximately only 40% of drugs in the Physicians’ Desk Reference are labeled with a pregnancy risk category.3 Among the drugs that have been evaluated for pregnancy risks, 70% have a Category C assignment.2

Historically, some drug therapies used during pregnancy have been associated with harm to the fetus or infant. For example, prior to the 1960s, use of thalidomide to treat pregnancy-related nausea and vomiting led to severe teratogenesis in thousands of children worldwide; they experienced limb underdevelopment and major deformities.2 Because of this tragedy, the federal government created legislation to ensure safer use of prescription drugs during pregnancy. The Kefauver-Harris Amendments of 1962 established a stricter drug approval process that would require initial proof of safety and efficacy.3 Today the U.S. Food and Drug Administration (FDA) has additional safety regulations in place, including specific requirements for clinical trials. For example, before a drug may be studied in pregnant women, there are requirements of at least one animal species study to understand its fertility and reproductive effects; at least two animals species studies for to observe its teratogenic effects; and perinatal and postnatal analyses before it can be administered during pregnancy, labor and delivery.3

Prior to 1979, most prescription drugs included nonspecific safety statements in the label, such as “safe use in pregnancy has not been established”.3 However, the Prescription Drugs Used in Man regulation passed in 1979 crafted the model of five letters of risk categories for pregnancy. This was the system in place to evaluate drug safety and efficacy in pregnant women, until new changes took place in June 2015.2 Table 1 reviews definitions and drug examples of the former pregnancy risk categories.

Risk Category Definition Summary2 Examples
A Evidence supported by controlled studies in pregnant women demonstrate a failure to be of risk to the fetus in first trimester, and no evidence of risk in subsequent trimesters
Folic acid
Levothyroxine
B Failure to demonstrate a risk to fetus as supported by animal studies, while there are no studies in pregnant women; or animals studies exhibit an adverse effect, but human studies do not, and no evidence of risk in subsequent trimesters
Diphenhydramine
Metformin
Ondansetron
C
Human studies are lacking, and animal studies have either demonstrated an adverse effect in the fetus or there are no animal studies; 
Benefits of use in pregnant women may justify the potential risks
Metoprolol
Hydrocodone
Glipizide
D
Human studies, investigational or marketing experiences exhibit evidence of human fetal risk;
Potential benefits to pregnant women may outweigh the potential risks
Alprazolam
Lithium
Phenytoin
X
Human or animal studies exhibit fetal abnormalities, or evidence of risk to fetus from investigational and/or marketing experiences;
Risks of use in pregnant women definitely outweighs any potential benefits
Statins
Benzodiazepines
Contraceptive hormones


This former system included the Pregnancy Subsection in package inserts of prescription drugs. The subsection was not a requirement for drugs unabsorbed systemically or showing no potential risks to the fetus.1 There is no standard system for risk classification of lactation.4

Concerns with Current Labeling
There are several concerns that have been identified with the previous letter-category system. First, there is unclear and confusing information to describe the risks of medication use in pregnancy and lactation.5 The category system does not clarify if available information comes from human or animal studies. For example, category B may mean animal studies show risk but human studies do not, or that human data is unavailable but animal studies show no harm.6 Secondly, they are too simplistic to accurately describe when in fetal development toxicity or teratogenicity can occur. For example, phenytoin may affect neural tube development with the highest risk of teratogenesis in organ development occurring in the first trimester.2 SSRIs may have effects on fetal neurobehavioral development, mostly likely occurring in the third trimester. This can result in withdrawal syndromes in the neonatal period, or in drug excretion in breast milk.  Additionally, the letter system is also too simplistic in describing types of potential teratogenic adverse outcomes; for example, nonspecific terms such as “fetal abnormalities” or “fetal risk” are used to describe fetal harm.2

The categories are ambiguous and can result in multiple interpretations.5 For example, the majority of drugs are Category C for varying reasons. It could be because human data are lacking, and animal data are either lacking or show adverse effects in offspring, or it could mean that risks are not ruled out, thus maternal benefits may potentially outweigh risks of using the drug.3 This rating system creates a deceiving impression of comparative or graded risks of drugs between the categories.5 For example, thalidomide, isotretinoin, and oral contraceptives are Category X. Thalidomide and isotretinoin are highly teratogenic and toxic to fetal development; whereas, oral contraceptives receive this rating due to their lack of benefit during pregnancy (i.e., they do not prevent pregnancy in an established pregnancy).6 In actuality, categories A, B, and C represent the evidence available for a drug’s potential for fetal harm.1 Categories D and X represent information about fetal harm risks weighed against potential benefits to maternal health.4

The letter system offered a lack of meaningful information to counsel patients on drug use safety.5 It was originally designed as a prospective guide for drug use during pregnancy, and therefore does not address inadvertent embryo or fetal drug exposure in unplanned pregnancies. There is no information on the types, frequency, and severity of complications that may occur with medications used during an unknown pregnancy. Additionally, there are no recommendations for pregnancy testing and fertility effects with drug therapies either. 

Revised Labeling – The Pregnancy and Lactation Labeling Rule (PLLR)
The U.S. FDA proposed the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling in 2008.5 This work is the result of decades of research; feedback from clinicians and various professional organizations, such as the Teratology Society; focus groups; and public hearings.6,7

The revised label includes the following new subsections: Pregnancy, Lactation, and Females and Males of Reproductive Potential, replacing the former subsections in package inserts (Pregnancy; Labor and Delivery; and Nursing Mothers).

The content and format revisions apply to labels of prescription drugs and biological products, while over-the-counter drugs are unaffected.7

Outline of new format8

  • 8.1 Pregnancy subsection
    • Pregnancy Exposure Registry*
      • Pregnancy exposure registry contact information, if available for particular drug
    • Risk Summary
      • Risk statement summary of developmental harm based on all data
    • Clinical Considerations
      • Embryo/fetal risk associated with maternal conditions
      • Pregnancy and postpartum period drug dosage adjustments
      • Adverse effects on mother
      • Adverse effects on fetus/infant
      • Monitoring parameters for mother/fetus/infant
      • Labor or delivery information
    • Data
      • Description of data basis (human data and/or animal data)
  • 8.2 Lactation
    • Risk Summary
      • Effects of drug exposure through breast milk on breastfed child
      • Effects on milk production of drug and/or active metabolites
      • Concentration of drug in breast milk including calculation to corresponding pediatric dosing if available
    • Clinical Considerations
      • Exposure minimization information
      • Adverse effects and monitoring parameters
    • Data
      • Description of data basis (human data and/or animal data)
  • 8.3 Females and Males of Reproductive Potential*
    • Pregnancy Testing
    • Contraception
      • Contraception use and pregnancy testing recommendations prior, during, or after medication use
    • Infertility
      • Fertility effects from drug use and its data basis (human and/or animal)
*Subheadings and information may be omitted when not applicable.

The new format eliminates the pregnancy letter categories, and instead offers increased precision of data and organization of labeling. For example, in the Pregnancy - Clinical Considerations subheading specific teratogenic adverse outcomes are noted, such as embryo or fetal death; structural deformities; fetal growth disturbances; and/or deficits in physiological function.3,7

The new labeling became effective June 30, 2015.7 Drugs that were approved before June 30, 2001 are not required to implement these changes; however, those manufacturers will have 3 years to remove pregnancy risk category letter, and may volunteer to update their labels with the new content.9 Drugs that were approved after June 30, 2001 are required to comply with the new format. Specifically, those approved between June 30, 2001 and June 30, 2015 will be required to update their labels in phases over 3-5 years.9 Drug applications seeking FDA approval submitted on or after the Rule’s effective date are required to implement the new format immediately.9

Implications to practice
With the new drug labeling comes more comprehensive data that will need to be interpreted carefully. Familiarity with the new content and format is necessary for healthcare providers to be able to counsel accurately on multiple aspects and stages of reproduction, including medication use effects and benefits on reproductive potential, in pregnancy, during lactation, and in the neonatal period; as well as in forming recommendations for pregnancy testing and contraception use. Decisions will involve considering patient-specific factors rather than relying on simple categorizations. Pharmacists should be prepared to serve as a resource for interpreting and applying this information to other healthcare providers and patients.

Summary
The pregnancy categories will phase out beginning June 30, 2015. Manufacturers of drugs approved after 2001 will have 3-5 years to comply with the new labeling. However, this mandate is effective immediately for recently approved drugs. The new labeling will include more detailed and comprehensive information for prescribing and counseling and may necessitate more time and effort by healthcare providers to read, understand, and apply the information to pregnant patients.  For pharmacists, specifically, the new labeling may change the way we consider decision-making in risks vs. benefits of medications in pregnant patients.

More information on the new labeling can be found at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm


References
  1. Mazer-Amirshahi M, Samiee-Zafarghandy S, Gray G, et al. Trends in pregnancy labeling and data quality for US-approved pharmaceuticals. Am J Obstet Gynecol. 2014;211:690.e1-11.
  2. Ramoz LL, Patel-Shori NM. Recent changes in pregnancy and lactation labeling: retirement of risk categories. Pharmacotherapy. 2014;34(4):389-95.
  3. Doering PL, Boothby LA, Cheok M. Review of pregnancy labeling of prescription drugs: is the current system adequate to inform of risks? Am J Obstet Gynecol. 2002;187:333-9.
  4. Howland RH. Categorizing the safety of medications during pregnancy and lactation. J Psychosoc Nurs. 2009;47(4):17-20.
  5. U.S. Federal Register. Proposed Rule: Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. http://www.gpo.gov/fdsys/pkg/FR-2008-05-29/html/E8-11806.htm (accessed 2015 Jun 3).
  6. Feibus KB. FDA’s proposed rule for pregnancy and lactation labeling: improving maternal child health through well-informed medicine use. J Med Toxicol. 2008 Dec;4(4):284-8. 
  7. U.S. Food and Drug Administration. Pregnancy and lactation labeling final rule. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm093307.htm (accessed 2015 Jun 3).
  8. U.S. Food and Drug Administration. Outline of Section 8.1 – 8.3 on drug labeling. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm425415.htm (accessed 2015 Jun 3).
  9. U.S. Department of Health and Human Services. Pregnancy, lactation, and reproductive potential: labeling for human prescription drug and biological products — content and format guidance for industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM425398.pdf (accessed 2015 Jun 3).

ICHPeople

ICHP was very sad to hear of the passing of past ICHP member, Toby ClarkToby is the former Director of Pharmacy at the University of Illinois Hospital & Health Science System in Chicago.  Toby was an active ICHP member while in Illinois and a very active ASHP member throughout his career.  Toby retired from U of I and moved to Charleston, SC where he continued to survey residency programs for ASHP’s Residency accreditation service.  He also provided consulting services across the country. 



















Leadership Profile
Brandi Strader, Pharm.D.

What is your current leadership position in ICHP?

I just completed my term as the New Practitioners Network (NPN) Chair. As the New Practitioners Network Chair, I used my skills and motivation to promote and develop pharmacy at the local and state level. 

What benefits do you see in being active in a professional association such as ICHP?

Collaboration with pharmacists with the same goal – to move our profession forward. I have been inspired by the organization and its ability to make a large impact on a young pharmacist’s career path. 

What initially motivated you to get involved in ICHP?

I was encouraged by a mentor to attend ICHP and present my research in the emergency department which is where all of my professional focus had always been. I quickly realized that ICHP had several opportunities to expand my energy and motivation to improve pharmacy on a larger scale and not just in my hospital.  

Later as a preceptor, I attended ICHP to support my students and residents and was quickly motivated to get more involved and be a part of change in Illinois pharmacy. 

Where did you go to pharmacy school?

SIUE School of Pharmacy, Class of 2009

Where have you trained or worked

I completed a PGY-1 residency program at Methodist University Hospital in Memphis TN. Thereafter, I started the emergency department pharmacy program at HSHS St. John’s Hospital in Springfield, IL and later obtained board certification in pharmacotherapy (BCPS).

Describe your current area of practice and practice setting.

I’m currently the Clinical Manager and PGY-1 Residency Director at HSHS St. John’s Hospital in Springfield, IL. I help lead clinical initiatives and direct the PGY-1 residents at my practice site. I am also involved in formulary review and implementation for our hospital system, Hospital Sisters Health System. I lead several clinical and cost savings initiatives across the hospital system including quality measures to ensure optimal patient care and reimbursement.   

Is there an individual you admire or look up to, or a mentor that has influenced your career?

As a student I worked several years as an intern in a retail setting. After my first rotation in a hospital under the direction of an excellent preceptor (Katie Ronald) in the ICU, I was convinced that I needed to change my focus to hospital pharmacy and complete a residency.  

What advice would you give to student pharmacists?

Keep pushing yourself to obtain your goals, and if you do not have goals, set them now!

Do you have any special interests or hobbies outside of work?

I love spending time with my two boys and husband and playing and watching sports.

Do you have a favorite restaurant or food?

Anything Italian.

What is your favorite place to vacation?

Vacation, what is that?



Government Affairs Report
Time to Review Federal Regs and Standards

by Jim Owen and Scott Meyers

While the Illinois Budget stalemate continues, there are a few issues to report on in this month’s Government Affairs Report. October 27th was the deadline for comments on HRSA’s 340B Megaguidance released in August. ICHP’s Government Affairs Division crafted our concerns and forwarded them to the agency. With the help of JoAnn Stubbings and a summary of points from an organizations named 340B Health, the Division discussed specific points.  
  • Hospital relationships with providers – The new guidance requires that 340B hospitals (covered entities) must have an employment or contracted relationship with the prescribing provider. This creates a variety of problems for the covered entities, and ICHP has recommended this change be removed.
  • Discharge Prescriptions – The new guidance does not allow the use of 340B medications for patients being discharged. These meds are often provided to the patient at no cost in order to prevent readmissions and are used in the outpatient session. It is unfair to prevent the use of the lower costs medications in these situations, so ICHP has recommended that this change be removed also.
  • Bundled Medicaid Medications – This change would exempt the use of 340B medications in outpatient procedures that have a bundled Medicaid payment. The payment is intended to cover the costs of all medications, supplies and services provided in outpatient procedures and the use of 340B medications would allow the covered entity to reduce overall costs. This section of the guidance would create issues with inventory management and tracking. ICHP recommended it be removed.
  • GPO prohibition - The new guidance requires clarification regarding the three exceptions to the GPO prohibition guidance. The guidance states that a clinic must purchase medications using a separate account from the 340B parent covered entity. It is unclear whether this means that each non-340B enrolled clinic must have a separate GPO account or contract or whether all non-340B enrolled affiliated clinics of a covered entity can purchase medications through a single GPO account or contract.  It is also unclear if this also applies to non-340B clinics located within the walls of the covered entity to use the same GPO account or contract. ICHP asked for significant clarification of this section.
  • Contract Pharmacy - The guidance requires the covered entity to conduct annual audits and quarterly reviews of each contract pharmacy location which would be time and cost prohibitive. Many of the contract pharmacies have multiple locations with centralized software. In addition, the covered entity is responsible for all child sites which would use the same contract pharmacy. ICHP recommends that an annual audit of the central system should be sufficient to provide compliance and because the covered entity is responsible for all child sites, it is unnecessary to list them separately as using the contract pharmacy.
The Division is now reviewing two additional issues with comment deadlines. The first is from the federal Environmental Protection Agency, which has issued draft rules regarding Hazardous Waste Disposal. Comments on these proposed regulations must be submitted on or before November 24, 2015. Preliminary review of the proposed changes indicates very little changes for hospital pharmacies, but a complete review will be conducted and any necessary comments will be submitted by the deadline.

The other issue in the hands of ICHP’s Division of Government Affairs is the proposed changes to USP Chapter 797. The deadline for comments on this significantly revised USP Chapter are due by January 31, 2016. This revision is especially important as the Illinois Department of Financial and Professional Regulation is drafting compounding standards for the Illinois Pharmacy Practice Act that are expected to require compliance with several USP Chapters including 797. A full review of the revised chapter will be conducted before the January deadline.

ICHP’s Division of Government Affairs meets every month, normally on the third Monday of the month via conference call to address legislative and regulatory issues facing Illinois pharmacies. If you are interested in participating in ICHP advocacy efforts, contact Kathryn Schultz, Division Director at Kathryn_Schultz@rush.edu or Scott Meyers, ICHP Executive Vice President at scottm@ichpnet.org



College Connection

High Risk Readmission Program: A Rotation Experience

by Kelsea Caruso, PS-4, Midwestern University Chicago College of Pharmacy

In 2012, Medicare implemented a Hospital Readmissions Reduction Program to avoid preventable hospital readmissions leading to an increase in cost to the health system. Hospitals run the risk of not being fully reimbursed for their services if certain patients are readmitted within 30 days of the last discharge. Currently, the program is evaluating readmissions for heart attack, heart failure, pneumonia, hip and knee replacements, and COPD. Hospitals are responsible for starting their own program to identify potential patients as high-risk readmissions. 

During my general medicine rotation at Northwestern Memorial Hospital (NMH), I had the opportunity to participate in an initiative that targets patients who are likely to be readmitted. At NMH, the High Risk for Readmission program identifies patients who are likely to be readmitted to the hospital within 30 days. Many factors contribute to a patient qualifying as “high risk for readmission”, including past readmissions, comorbid disease states, and other potential factors. This program has the ability to identify any patient with any reason for admission, not just those included on the Medicare list. The goal of this program is to improve patient outcomes while decreasing the likelihood of readmission and decreasing the cost to the overall health system. 

Upon admission to the hospital, all patients receive admission medication reconciliation, verifying that their home medications are accurate and that they are appropriately ordered during their inpatient stay. While completing the medication reconciliation, I would always address adherence and pick-up on clues from the patient about their medication adherence. If a patient was having problems with adherence, I would address those issues during my discharge counseling. Simple things like changing the time of the day the patient takes their medication can significantly improve their adherence. 

Patients who are identified as high-risk for readmission receive discharge counseling on medications from a pharmacist or student pharmacist. Discharge counseling normally occurs the day prior to or the day of discharge. To prepare for a safe and successful discharge, the interdisciplinary medical team (including physicians, nurses, social workers, nutritionists and pharmacists) meets to discuss the patient’s discharge plan. The pharmacist and student then have the opportunity to evaluate the discharge medications that are prescribed by the physician team and recommend any additional changes. For each patient, I would create a medication list, which included the indication for the medication, dose, including amount (mg) and number of tablets, what time of the day to take the medication, and any special instructions for that medication. This process of creating a medication list was the most patient friendly and allowed for individualization. 

When the team cleared the patient for discharge, I would provide medication education and address any barriers to appropriate medication use. I would focus my time counseling on new medications that had been started in the hospital. After reviewing the new medications, I would reinforce past medications. While counseling, I would ensure the patient understood the indication and rational for use of each medication. 

As some patients rely on family or caregivers to assist them with their medications, I would make sure that the family or caregiver was present for the discharge counseling if this were the case. It is important that they, like the patient, understand the purpose of the medications and instructions with those medications. 

Throughout my six weeks at NMH on internal medicine, I counseled numerous patients about their discharge medications and played a role in improving outcomes, quality of life, and decreasing their chance for readmission. I found that many of these patients were not taking their medications properly or did not understand why they were taking the medication. This speaks to the importance of medication education within the inpatient setting and the unique qualifications pharmacists have, as medication experts, to impact this patient population. Counseling these patients was a rewarding experience because I really felt like I helped them get a better grasp on their medications. It is important that these patients continue to be identified as high-risk for readmission, not only to decrease their healthcare costs, but also to improve overall patient care and outcomes.  
 

More

Welcome New Members!

New Member Recruiter
Andrew Bolis
Vishal Kumar
Claire Suh
Kristel Apolinario
Hai Nguyen
Omar Hernandez Scott Drabant
Amin Virani
Christopher Siegler
Yesha Patel
Amanda Thoma
Steven Toepfer
Paul Thames
Vrinda Naik
Sheron Chen
Manuel Gomez
Alice Aganze
Lindsey Percak Jan Keresztes
Jenny Vyskocil Jordan Faison
Julia Gilbert
Daniella Smid
Janet Ellis
Eric Huff
Jamal Sims
Abigail Rodeghiero
Nicole Eigenbrodt
Jessie Johnson
Timothy Cruz
Maddie VanDaele
Clayton Whittington
Jeremy Andis
Chloe Stason
Rachel Kozinski
Rikii Pyle
John Talili
Brandy Hudgins
Kimberley Shubert
Kaylee Poole
Lauren Skarupa
Alyssa Yousif
McWade Palmer
Ellen Chackunkal
Xuan Mai Vien
Michelle Yu
Michael Aquino
Jay Pandya
Yvonne Lai
Chad Lothary John Barker
Marilyn Gaske
Tran Tran Jill Borchert

Officers and Board of Directors

Election Results
President-elect Charlene Hope
Secretary-elect Katherine Miller
Director-elect, Educational Affairs Lara Ellinger
Director-elect, Marketing Affairs Carrie Vogler
New Practitioners Network Chair-elect Colleen Czerniak
Technician Representative-elect Clara Gary


JENNIFER PHILLIPS
 
President
630-515-7167 
jphillips@midwestern.edu 

LINDA FRED 
Immediate Past President
217-383-3253 
linda.fred@carle.com

CHARLENE HOPE
President-Elect
708-783-5933

JENNIFER TRYON 
Treasurer 
jennifer.tryon@uchospitals.edu 

CHARLENE HOPE
Secretary
708-783-5933

TRAVIS HUNERDOSSE 
Director, Educational Affairs 
thunerdo@nmh.org

CARRIE VOGLER
Director, Marketing Affairs
217-545-5394

DESI KOTIS 
Director, Professional Affairs
312-926-6961 
dkotis@nmh.org

CAROL HEUNISCH 
Director, Organizational Affairs 
847-933-6811

KATHRYN SCHULTZ
Director, Government Affairs
312-926-6961

MIKE WEAVER 
Chairman, House of Delegates 
815-599-6113 
mweaver@fhn.org

ANA FERNANDEZ
Technician Representative
312-926-6980

DAVID TJHIO
 
Chairman, Committee on Technology 
816-885-4649 
david.tjhio@cerner.com

REBECCA CASTNER
Chairman, New Practitioners Network
773-821-2164

JACOB GETTIG 
Editor & Chairman, KeePosted Committee 
630-515-7324 fax: 630-515-6958 
jgetti@midwestern.edu 

JENNIFER PHILLIPS 
Assistant Editor, KeePosted 
630-515-7167 
jphillips@midwestern.edu 

SCOTT MEYERS 
Executive Vice President, ICHP Office 
815-227-9292 
scottm@ichpnet.org 

Regional Directors

NOELLE CHAPMAN 
Regional Director North
312-926-2547
nchapman@nmh.org 

ED RAINVILLE 
Regional Director Central 
ed.c.rainville@osfhealthcare.org 

LYNN FROMM 
Co-Regional Director South
618-391-5539

TARA VICKERY GORDEN 
Co-Regional Director South
618-643-2361 x2330
tvgorden@hmhospital.org

Student Chapter Presidents

KATHERINE SENCION 
President, Student Chapter
University of IL C.O.P. 
ksenci2@uic.edu 

JOANNE CHA 
President, Rockford Student Chapter 
University of IL C.O.P. 
cha17@uic.edu

JESSICA PENG 
President, Student Chapter
Midwestern University C.O.P. 
jpeng54@midwestern.edu

BRITTANY HUFF
 
President, Student Chapter 
Chicago State University C.O.P. 
bhuff@csu.edu

WHITNEY MAHER 
President, Student Chapter 
Southern Illinois University Edwardsville S.O.P
whitney.maher@gmail.com

JORDAN FAISON 
President, Student Chapter 
Roosevelt University C.O.P. 
jfaison@mail.roosevelt.edu

VALENTIN PACURARU 
President, Student Chapter 
Rosalind Franklin University C.O.P. 
valentin.pacararu@my.rfums.org


ICHP Affiliates 


KATHRYN SCHULTZ 
President, Northern IL Society (NISHP)

JARED SHELEY 
President, Metro East Society (MESHP)
jpsheley@gmail.com 

AMY BOBLITT 
President, Sangamiss Society
Boblitt.amy@mhsil.com

ED RAINVILLE
 
President, West Central Society (WSHP)  
ed.c.rainville@osfhealthcare.org

Vacant Roles at Affiliates — 
President, Rock Valley Society; Southern IL Society; Sugar Creek Society

ICHP Pharmacy Action Fund (PAC) Contributors

Names below reflect donations between November 1, 2014 and November 1, 2015. Giving categories reflect each person's cumulative donations since inception.

ADVOCACY ALLIANCE - $2500-$10000
Kevin Colgan
Edward Donnelly
Dave Hicks
James Owen Consulting, Inc.
Scott Meyers
Michael Novario
Michael Weaver
Thomas Westerkamp

LINCOLN LEAGUE - $1000-$2499
Scott Bergman
Andrew Donnelly
Ginger Ertel
Linda Fred
Ann Jankiewicz
Jan Keresztes
Kathy Komperda
Despina Kotis
William McEvoy
Michael Rajski
Christina Rivers-Quillian
Carrie Sincak
Avery Spunt
JoAnn Stubbings
Patricia Wegner

CAPITOL CLUB - $500-$999
Sheila Allen
Margaret Allen
Rauf Dalal
Leonard Kosiba
George MacKinnon
Janette Mark
Mary Lynn Moody
Jennifer Phillips
Edward Rainville
Kathryn Schultz
Jill Warszalek

GENERAL ASSEMBLY GUILD - $250-$499
Peggy Bickham
Jaime Borkowski
Brad Dunck
Nancy Fjortoft
Joann Haley
Travis Hunerdosse
Kim Janicek
Mary Lee
Karen Nordstrom
Peggy Reed
Kristi Stice
Heidi Sunday
Tara Vickery-Gorden
Marie Williams

SPRINGFIELD SOCIETY - $100-$249
Jill Borchert
Noelle Chapman
Kathy Cimakasky
Christopher Crank
Joan Hardman
Glenna Hargreaves
Robert Hoy
George Lyons
Dylan Marx
James Sampson
Brandi Strader
Carrie Vogler
Amanda Wolff

GRASSROOTS GANG - $50-$99
Gunchoo Chadha
Lara Ellinger
Jennifer Ellison
Bella Maningat
Robert Miller
Julio Rebolledo
Jerry Storm

CONTRIBUTOR - $1-$49
Marc Abel
Anchalee Ardharn
Skylar Boldue
Antoinette Cintron
Janet Engle
Linda Grider
Heather Harper
Ina Henderson
Antoine Jenkins
Connie Larson
Barbara Lindberg-Mancini
Michelle Martin
Natalie Schwarber
Karin Terry

Upcoming Events

Visit the ICHP Calendar for the most up-to-date events!Visit the ICHP Calendar for the most up-to-date events!

Wednesday, November 11, 2015 | 12:00pm and
Tuesday, November 17, 2015 | 3:00pm
Establishing Inpatient Medication Therapy Management Billing
Deborah L. Sanchez, RPh, PharmD, BCPS
Champions Program
LIVE Webinar
Accredited for pharmacists and pharmacy technicians | 0.5 credit hour ( 0.05 CEU)

Thursday, November 19, 2015 | 6:00pm
Biologics and Biosimilars: Preparing for the Future
Alissa Segal, PharmD
NISHP Program
Nia Mediterranean Restaurant | Chicago, IL
Accredited for pharmacists | 1.0 credit hour ( 0.1 CEU)

Thursday, December 3, 2015 | 6:00pm
I've got a Fever, and the only prescription is parenteral iron
Dawn Dankenbring, PharmD, BCPS
MESHP Program
St. Elizabeth's Hospital | Belleville, IL
Accredited for pharmacists and pharmacy technicians | 1.0 credit hour ( 0.1 CEU)

Tuesday, December 15, 2015 | 6:00pm
Procalcitonin, Antibiotics, and You! How this Biomarker can be Applied to Clinical Practice 
Lyle Pratt, PharmD
Sangamiss Program
Fire and Ale | Sherman, IL
Accredited for pharmacists and pharmacy technicians | 1.0 credit hour ( 0.1 CEU)




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